1. Scrip
  2. >>Therapy Areas
  3. >>Anticancer

Future Of TG’s Ukoniq In Question As Drug Attracts Closer FDA Scrutiny

 
• By Alaric DeArment

The agency has suspended enrollment in Ukoniq trials while also hinting at greater scrutiny of “the continued marketing” of the drug.

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science to detection, monitoring, and prevention of adverse effects with pharmaceutical product. Medical safety concept
TG's Ukoniq has come under increased FDA scrutiny over its safety-efficacy profile • Source: Shutterstock

Safety concerns that led to the US Food and Drug Administration placing a partial clinical hold on some trials of TG Therapeutics, Inc. PI3K-delta inhibitor Ukoniq (umbralisib) are looking potentially more serious as the FDA is now also looking into the overall safety-efficacy profile of Ukoniq for its marketed indications, follicular lymphoma (FL) and marginal zone lymphoma (MZL).

TG had initially disclosed on 27 January that the FDA placed a partial clinical hold on studies of Ukoniq combined...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Anticancer

After Gilead Deal, Hookipa Hangs Up Its Hat

 
• By Kevin Grogan

The Austrian firm is delisting from the NASDAQ and closing down.

Genentech Gets Columvi Complete Response Following ODAC’s No

 
• By Joseph Haas

Seeking to move Columvi into second-line DLBCL, Genentech got an FDA letter saying the Phase III STARGLO study’s benefits may have been driven by results in Asian enrollees.

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?

More from Therapy Areas

BMS’s Reblozyl Misses Primary Endpoint In Myelofibrosis Anemia

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III INDEPENDENCE trial, which did meet key secondary endpoints.

Insmed’s New R&D Site Focused On ‘Synthetic Rescue’

 
• By Andrew McConaghie

A new small-molecule approach to turning on beneficial genes to counteract disease-causing mutations is being pioneered by Insmed’s UK-based scientists.

AI-First, Big Pharma, Chinese Firms In Race - What’s Ahead For PRMT5 Inhibitors

 
• By Vibha Ravi

As AI-driven firms including Insilico, big pharmas J&J, Amgen, GSK and AstraZeneca and Chinese and Indian firms like BeOne and Dr. Reddy’s advance PRMT5 inhibitor candidates, what’s driving interest, what could lead to the first global approval and what are the challenges ahead?